Jaw, Edentulous, Partially
Conditions
Keywords
jaw, edentulous, partially
Brief summary
The purpose of this study is to compare two different techniques of placing dental implants: 1) removing the tooth and placing the implant immediately and 2) removing the tooth and placing both the implant and a temporary crown immediately. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best implant placement technique for their patients.
Detailed description
To qualify, patients must be between 18 to 79 years old, in good health, have a tooth in the upper jaw (except molars) that needs to be extracted, and able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months). Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator Patients will be excluded for any of the following conditions: Women who are pregnant or plan to become pregnant, an existing implant adjacent to the area of study, current smoker or quit smoking less than one year ago, antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition), chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...), current orthodontic treatment, or active periodontal treatment. Participants must inform the investigators if they are enrolled in any other studies because it may becloud them from participation in this study.
Interventions
DEVICEimmediate implant placement without provisionalization
DEVICEimmediate implant placement with immediate provisionalization
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* between 18 to 79 years old * in good health * have a single tooth in the upper jaw (except molars) that needs to be extracted * able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months) * Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator
Exclusion criteria
* an existing implant adjacent to the area of study * current smoker or quit smoking less than one year ago * antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition) * chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...) * current orthodontic treatment, or active periodontal treatment * Women who are pregnant or plan to become pregnant during the course of the study, and nursing mothers * unstable medical condition or if you are unable to have routine dental surgery then you should not participate in this study. If you are already participating in another study, we ask that you inform the investigators because participating in more than one study may be harmful to you.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue Diemensional Change | Baseline, 12mo after baseline | Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival | 2wk, 4wk, 6wk, 3mo, 6mo, 12mo | Checking to make sure the implant is stable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bony Dimensional Changes | Baseline, 6mo & 12mo after baseline | Measurements will be based off of standardized x-rays and CBCT. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Implant Placement Without Provisionalization The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
immediate implant placement without provisionalization | 2 |
| Immediate Implant Placement With Immediate Provisionalization The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
immediate implant placement with immediate provisionalization | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Immediate Implant Placement Without Provisionalization | Immediate Implant Placement With Immediate Provisionalization | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 2 / 2 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Soft Tissue Diemensional Change
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Time frame: Baseline, 12mo after baseline
Population: Data was not collected.
Secondary
Implant Survival
Checking to make sure the implant is stable.
Time frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Implant Placement Without Provisionalization | Implant Survival | 2wk | 2 Participants |
| Immediate Implant Placement Without Provisionalization | Implant Survival | 4wk | 2 Participants |
| Immediate Implant Placement Without Provisionalization | Implant Survival | 6wk | 2 Participants |
| Immediate Implant Placement Without Provisionalization | Implant Survival | 3mo | 2 Participants |
| Immediate Implant Placement Without Provisionalization | Implant Survival | 6mo | 2 Participants |
| Immediate Implant Placement Without Provisionalization | Implant Survival | 12mo | 2 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 6mo | 1 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 2wk | 3 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 3mo | 1 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 4wk | 2 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 12mo | 1 Participants |
| Immediate Implant Placement With Immediate Provisionalization | Implant Survival | 6wk | 1 Participants |
Other Pre-specified
Bony Dimensional Changes
Measurements will be based off of standardized x-rays and CBCT.
Time frame: Baseline, 6mo & 12mo after baseline
Population: Data was not collected